Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML)

Novartis

Status and phase: Completed; Phase 4

Conditions: Chronic Myelogenous Leukemia

Treatments: Drug: imatinib mesylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00171899

CSTI571ACA09

Details and patient eligibility

About

The study will assess the role of high-dose imatinib mesylate, in patients who have taken imatinib mesylate for at least 1 year at the standard dose, in achieving a major molecular response (a measure of the level of chronic myelogenous leukemia) versus the standard dose.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic myelogenous leukemia with Philadelphia chromosome
• 18 years and older
• Patients must have been taking imatinib mesylate standard dose for at least 12 months and have achieved a complete cytogenetic response but not a major molecular response.

Exclusion criteria

• Patients with cardiac problems such as congestive heart failure, or myocardial infarction within the last 6 months
• Patients with an uncontrolled medical disease such as uncontrolled diabetes, chronic renal (kidney) disease or active uncontrolled infection.
• Patients with other current primary malignancy or malignancy requiring active intervention

Other protocol defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

80 participants in 1 patient group

STI571

Experimental group

Treatment:

Drug: imatinib mesylate